Regulatory Focus™ > News Articles > FDA Releases Guidance Document on Soon-To-Be-Mandatory Device Submission Program

FDA Releases Guidance Document on Soon-To-Be-Mandatory Device Submission Program

Posted 16 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new draft guidance document on a new digital medical device submission system.

The system, known as the eCopy Program, is soon to be required of certain manufacturers under the terms of the recently passed FDA Safety and Innovation Act (FDASIA), Section 745A(b).

As explained by FDA, "An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a CD, DVD, or in another electronic media format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the complete original paper submission." The system is currently voluntary.

FDASIA states that the system will come into effect 24 months after FDA issues final guidance to industry, and will apply to all devices submitted to the agency under sections 510(k), 513(f)(2)(A), 515(c), 515 (d), 515(f), 520(g), 520(m), or 564 of the Federal Food, Drug and Cosmetic Act. In addition, certain pre-submissions and any biological device submitted under Section 351 of the Public Health Service Act (PHSA) will also be required to submit application using the eCopy Program.

FDASIA established two requirements for the eCopy guidance: It must provide standards for what is required to be submitted using the electronic copy, and must establish criteria and waivers for exemptions from the program.

As such, FDA's guidance identified three types of applications exempt from its eCopy mandate: Compassionate use investigational device exemption (IDE) submissions, emergency use IDE submissions and emergency use authorizations (EUAs).

No other exemptions will be given due to the low cost and widespread availability of eCopy software, explained FDA.

The guidance goes on to list explicit details about how to submit an eCopy, steps to assure that a submission is up to FDA standards, how to submit to different FDA centers, and common mistakes made in submissions and how to avoid them.

Read more:

eCopy Program for Medical Device Submissions (FDA)

Draft Guidance for Industry and Staff; Availability: eCopy Program for Medical Device Submissions (Federal Register)

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